Achalasia CardiaNCT03186248
Randomized Clinical Trial Comparing Short Versus Long Oesophageal Myotomy in POEM for Achalasia Cardia.
A study testing Per oral endoscopic myotomy in people with Achalasia Cardia, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Aim of this study is to compare the outcomes of a short esophageal myotomy extending from 3 cm cephalad to the EGJ, to 3 cm distal to it with a long esophageal myotomy with an additional proximal extension (at least 6 cm cephalad to the EGJ, to 3 cm distal) for POEM procedures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Achalasia Cardia
- What is being tested?
- Per oral endoscopic myotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2017to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 and 2 achalasia with eckerd score >3 (0-12 scale achalasia) -.
- Age 18-75 years.
- Treatment naïve or history of pneumatic balloon dilatation.
- Willing and able to comply with the study procedures and provide written informed consent form to participate in the study.
Who cannot join
- Type 3 achalasia cardia or any other esophageal motility disorder
- Previous surgery of the esophagus or stomach
- Active severe esophagitis
- Large lower esophageal diverticula
- Large > 3cm hiatal hernia
- Sigmoid esophagus
Show all 9Show fewer
- Known gastroesophageal malignancy
- Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
- Cirrhosis with portal hypertension, varices, and/or ascites
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Short Versus Long Oesophageal Myotomy in Cases With Idiopathic Achalasia: A Randomized Single Blinded Trial
Aim of this study is to compare the outcomes of a short esophageal myotomy extending from 3 cm cephalad to the EGJ, to 3 cm distal to it with a long esophageal myotomy with an additional proximal extension (at least 6 cm cephalad to the EGJ, to 3 cm distal) for POEM procedures. Principle of POEM is to reduce pressure gradient across LES by Myotomy. Hypothesis is that performing short myotomy will result in similar efficacy in achalasia cardia while reducing the total time taken for the procedure and ultimately will result in less complications.
Read the detailed description
The primary goal of treatment of achalasia cardia (either LHM or POEM) is to divide the muscle at LES to reduce the pressure so that food bolus can pass down into the esophagus. However, there is little evidence regarding the optimal length of this myotomy for either procedure. During LHM the proximal length of myotomy is extended upto 6-8 cm in esophagus and distally to 3 cm in stomach. There are no data on long term outcomes between differential proximal myotomy lengths. The conventionally the esophageal myotomy is extended to 6-8 cm, this is based on technical considerations, as it is the maximum length that can safely be achieved via a laparoscopic, transhiatal approach. High pressure zone of Esophago gastric junction (EGJ) complex extends for 4 cm on an average with 2 cm on esophageal side. It is hypothesized that If shorter proximal myotomy that ablates just the EGJ complex could achieve the same normalization of EGJ physiology as a longer one, there could be several advantages to this modification. It will take less mediastinal dissection of the esophagus, potentially reducing the chances of esophageal perforation, vagal injury and pleural tears. During POEM, a shorter myotomy would allow for creation of a shorter submucosal tunnel, decreasing operative time along with potentially decreasing the incidence of mucosal perforations, pneumothorax and pneumoperitoneum. Additionally, there is chance that many patients regain some esophageal peristalsis after both LHM and POEM. Patients undergoing POEM for type 1 and type 2 Achalasia cardia will be randomised into 2 groups of short oesophageal (3 cm) and long oesophageal ( 6-8 cm) myotomy.
- Conditions
- Achalasia Cardia
- Being tested
- Per oral endoscopic myotomy
- Keywords
- Achalasia cardia, myotomy, Per oral endoscopic myotomy, laparoscopic fundoplication
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Per oral endoscopic myotomyProcedure or surgery
General anesthesia will be administered and an esophagogastroduodenoscopy will be performed. Mucosal incision proximal to the gastroesophageal junction (GEJ) will be identified depending on short or long myotomy. A 1.5- to 2-cm mucosal incision will be performed after raising a submucosal wheal. The endoscope will be inserted to create a submucosal tunnel with a combination of blunt dissection, carbon dioxide insufflation, hydro dissection and careful electrocautery. The tunnel will be extended past the GEJ, 3 cm onto the gastric cardia. after myotomy, the mucosal incision will then be closed using standard endoscopic clips.
| Study group | Role | What they receive |
|---|---|---|
| Short myotomy | Experimental | Per oral endoscopic myotomy extending from 3 cm cephalad to 3 cm distal to EGJ Receives: Procedure: Per oral endoscopic myotomy |
| Long myotomy | Active comparator | Per oral endoscopic myotomy extending from 6-8cm cephalad to and 3 cm distal to EGJ. Receives: Procedure: Per oral endoscopic myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinical efficacy between short and long myotomy groups
Clinical success defined as Eckardt score≤3 compared between the two groups
Measured: 1 year
Secondary outcomes (6)
Difference in operating time between short and long esophageal myotomy during POEM
Operating time defined as time taken from mucosal incision to closure of incision after completion of the procedure. Procedure duration was calculated in both the groups and compared
Measured: Intra-opeartive
Intraoperative adverse events
Adverse events encountered during the procedure will be noted. Clinical success with reference to improvement in eckerd score. Change in LES pressure by Manometry ( Assessed at 1and 3 months) Assessment of Gastro Esophageal Reflux Disease (GERD) by Potential of Hydrogen (pH) -impedance and Endoscopy (Assessed at 1 and 3 months) Change in barium column height on timed barium Esophagogram (Assessed at pre procedure at 1 and 3 months).
Measured: At the time of index procedure
LES pressure reduction
In both the arms reduction in mean LES pressure will be compared at 1 and 3 months
Measured: 1 and 3 months
Comparison of changes in Eckardt score
In both the groups Eckardt score ( based on symptoms of Dysphagia, Chest pain, regurgitation and weight loss) will be compared
Measured: 1, 3 and 12 months
Comparison of gastroesophageal Reflux disease (GERD) Rates
Both the groups will under go clinical evaluation, esophagograstroscopy and ph metry
Measured: 3 months
Change in barium column height on barium esophagogram
In both the groups time barium swallow studies will be done to evaluate the oesophageal emptying at 5 minutes.
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Jun 2017
- Primary completion15 Feb 2018
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achalasia CardiaStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- mahiboob sayyed, MD, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186248
- Sponsor's protocol ID
- AIG- 09/05
- Status last verified
- Dec 2019
- First submitted
- 9 Jun 2017
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short Versus Long Oesophageal Myotomy in Cases With Idiopathic Achalasia: A Randomized Single Blinded Trial
- ClinicalTrials.gov ID
- NCT03186248
- Acronym / sponsor ID
- AIG- 09/05
- Conditions
- Achalasia Cardia
- Keywords
- Achalasia cardia, myotomy, Per oral endoscopic myotomy, laparoscopic fundoplication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of this study is to compare the outcomes of a short esophageal myotomy extending from 3 cm cephalad to the EGJ, to 3 cm distal to it with a long esophageal myotomy with an additional proximal extension (at least 6 cm cephalad to the EGJ, to 3 cm distal) for POEM procedures. Principle of POEM is to reduce pressure gradient across LES by Myotomy. Hypothesis is that performing short myotomy will result in similar efficacy in achalasia cardia while reducing the total time taken for the procedure and ultimately will result in less complications.
Detailed description
The primary goal of treatment of achalasia cardia (either LHM or POEM) is to divide the muscle at LES to reduce the pressure so that food bolus can pass down into the esophagus. However, there is little evidence regarding the optimal length of this myotomy for either procedure. During LHM the proximal length of myotomy is extended upto 6-8 cm in esophagus and distally to 3 cm in stomach. There are no data on long term outcomes between differential proximal myotomy lengths. The conventionally the esophageal myotomy is extended to 6-8 cm, this is based on technical considerations, as it is the maximum length that can safely be achieved via a laparoscopic, transhiatal approach. High pressure zone of Esophago gastric junction (EGJ) complex extends for 4 cm on an average with 2 cm on esophageal side. It is hypothesized that If shorter proximal myotomy that ablates just the EGJ complex could achieve the same normalization of EGJ physiology as a longer one, there could be several advantages to this modification. It will take less mediastinal dissection of the esophagus, potentially reducing the chances of esophageal perforation, vagal injury and pleural tears. During POEM, a shorter myotomy would allow for creation of a shorter submucosal tunnel, decreasing operative time along with potentially decreasing the incidence of mucosal perforations, pneumothorax and pneumoperitoneum. Additionally, there is chance that many patients regain some esophageal peristalsis after both LHM and POEM. Patients undergoing POEM for type 1 and type 2 Achalasia cardia will be randomised into 2 groups of short oesophageal (3 cm) and long oesophageal ( 6-8 cm) myotomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Short myotomy | Experimental | Procedure: Per oral endoscopic myotomyPer oral endoscopic myotomy extending from 3 cm cephalad to 3 cm distal to EGJ |
| Long myotomy | Active comparator | Procedure: Per oral endoscopic myotomyPer oral endoscopic myotomy extending from 6-8cm cephalad to and 3 cm distal to EGJ. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 and 2 achalasia with eckerd score >3 (0-12 scale achalasia) -.
- Age 18-75 years.
- Treatment naïve or history of pneumatic balloon dilatation.
- Willing and able to comply with the study procedures and provide written informed consent form to participate in the study.
Key exclusion criteria (9 listed)
- Type 3 achalasia cardia or any other esophageal motility disorder
- Previous surgery of the esophagus or stomach
- Active severe esophagitis
- Large lower esophageal diverticula
- Large > 3cm hiatal hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Per oral endoscopic myotomyGeneral anesthesia will be administered and an esophagogastroduodenoscopy will be performed. Mucosal incision proximal to the gastroesophageal junction (GEJ) will be identified depending on short or long myotomy. A 1.5- to 2-cm mucosal incision will be performed after raising a submucosal wheal. The endoscope will be inserted to create a submucosal tunnel with a combination of blunt dissection, carbon dioxide insufflation, hydro dissection and careful electrocautery. The tunnel will be extended past the GEJ, 3 cm onto the gastric cardia. after myotomy, the mucosal incision will then be closed using standard endoscopic clips. | Procedure or surgery | Long myotomy, Short myotomy |
Primary outcome
Comparison of clinical efficacy between short and long myotomy groups
Time frame: 1 year
Clinical success defined as Eckardt score≤3 compared between the two groups
6 secondary outcomes
Difference in operating time between short and long esophageal myotomy during POEM
Time frame: Intra-opeartive
Intraoperative adverse events
Time frame: At the time of index procedure
LES pressure reduction
Time frame: 1 and 3 months
Comparison of changes in Eckardt score
Time frame: 1, 3 and 12 months
Comparison of gastroesophageal Reflux disease (GERD) Rates
Time frame: 3 months
Change in barium column height on barium esophagogram
Time frame: 1 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Individual participant dataSharing planned: No
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mahiboob sayyed, MD principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Per oral endoscopic myotomy in people with Achalasia Cardia, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of clinical efficacy between short and long myotomy groups (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.